3.1 Field of the Invention
The present invention relates to the management of medication dispensing and use, and, more particularly, to the management of medication dispensing and use for individuals who have complex medication regimens. Still more particularly, the present invention provides systems, methods, and software for managing medication dispensing and use for individuals that are not sedentary or otherwise restricted in their activities in ways that are relevant to their medication regimen. The present invention has applications in the fields of medicine, pharmacology, computer science, and robotics.
3.2 The Related Art
Although modern medicine offers powerful remedies and palliatives for many diseases once considered to be death sentences, such as cancer, heart disease, and many bacterial infections, patients undergoing treatment must adhere to treatment regimens that often include precisely scheduled drug administration over a specific and often lengthy time period. During the treatment period, which can be life-long for diseases such as AIDS, the patient must also maintain awareness of any possible unwanted or dangerous side effects that could warrant change in the regimen. Variance from the regimen, i.e., a failure of compliance, can diminish the therapeutic effectiveness of the regimen and lead to delayed recovery, complications in treatment, or even thwart effective treatment all together, which not only prolongs a patient's suffering but increases the cost of care. In some cases, the compliance failure arises from a patient's failure to take enough medication—i.e., by under-medication. In other cases, especially concerning pain management, compliance failure can lead to drug addiction by over-medication. In still other cases, a patient can take the prescribed amount of medication, but outside of the prescribed schedule, leading to the patient's being under- or over-medicated at different times. Moreover, patients can be on treatment regimens for multiple diseases or conditions that lead to adverse drug interactions that can be fatal in some instances, see, e.g., (Nies 1975; Tollefson 1993; Dennehy, Kishi et al. 1996; Tamblyn 1996; Beyth and Shorr 1999; Kubesova, Holik et al. 2006). Thus, providing sufficient education and assistance to better ensure patient compliance with treatment regimens is an important and growing concern among caregivers and insurers.
The general problem of patient compliance has been studied extensively (see, e.g., Herrmann and Gaus 1981; Peck and King 1982; Jay, Lift et al. 1984; Shope 1988; Tollefson 1993; Tamblyn 1996; Collingsworth, Gould et al. 1997; Vrijens and Goetghebeur 1997; Hausman 2001; Garcia Popa-Lisseanu, Greisinger et al. 2005; Mishra, Hansen et al. 2006), as well as in specific diseases including acne (Zaghloul, Cunliffe et al. 2005), osteoporosis (Gold and Silverman 2006), psoriasis (Zaghloul and Goodfield 2004), and cancer (Waterhouse, Calzone et al. 1993). Much has been written about compliance for chronic, long term diseases such as HIV-AIDS (Colombo 1997; Williams 1997; Garcia, Schooley et al. 2003; Goode, McMaugh et al. 2003; Berg, Demas et al. 2004; Carballo 2004; Halkitis, Kutnick et al. 2005; Nischal, Khopkar et al. 2005; Erlen and Sereika 2006; Slama, Le Camus et al. 2006), hepatitis C (HCV) (Braitstein, Justice et al. 2006), diabetes (Schafer, Glasgow et al. 1983; Sung, Nichol et al. 1998; Kalsekar, Madhavan et al. 2006), and treatments for mental illness (Diaz, Neuse et al. 2004; Farabee and Shen 2004; Nakonezny and Byerly 2006).
For example, a patient who is under therapy for a cancer typically takes a combination of prescription and non-prescription medications to help treat the disease and to strengthen his or her overall state of health. Often the patient obtains non-prescription medications, such as various vitamins and other nutraceuticals, from a retailer (either brick-and-mortar or online) in a variety of different forms and pill sizes. He or she further obtains drugs directly from their physician(s) or fills prescriptions with a pharmacist, and then adds the filled prescriptions to their growing collection of drugs. Moreover, the patient can be taking other medications, such as antibiotics, antihypertensives, anxiolytics, and the like to treat other conditions in addition their cancer. Each medication can have a different dosing schedule and can further have complex interactions with other medications, which the patient must keep track of.
One attempt at providing tools for the self-management of medications to patients is illustrated in FIGS. 1a and 1b. The prior art “pill box” provides a plurality of compartments, into which the patient loads the appropriate pill(s). Many different pill box configurations are possible, with individual compartments provided to support various use regimens. “Pill boxes” suffer from requiring the user to track whether they have enough medication to fill a pill box, have properly loaded medicines into the pill box and then whether they took their medication on schedule. Automated “pill boxes” and more complex systems, such as those described in U.S. Pat. No. 6,380,858 to Informedix of Rockville, Md., automate portions of managing a patient's taking their prescriptions, including providing audible reminders and tracking when a pill box provides a pill to a user. Collectively, these prior art medication organizing systems solve some problems while introducing others. Given the importance of this problem, the diversity of treatment regimens and sources of non-compliance, and complexities of reinforcing patient compliance, a variety of medication organizing devices have been devised; however, current devices have serious drawbacks, including:                Do not address prescription fulfillment issues, including out-of-stock and asynchronous fulfillments;        Do not address complexities inherent with loading and interacting with the medication organizing device;        Require the patient to be within audible range of a medication organizing device with audible alerts, which is effective only for persons having a sedentary lifestyle or a limited dosing schedule;        Are physician- or pharmacist-centric, and focus on prescription medications;        Fail to integrate prescription refills, non-prescription medications, and alternate dispensing formats;        Fail to limit the wastage, manage the disposal and permit recycling of unused medications;        Are ineffective at simplifying the life of a medication patient having numerous therapies, often with complex dosing, timing, interactions, and other restrictions; and        Are single-location devices.        
Prescriptions are typically provided by medical professionals when a patient visits the medical professional, and are generally for fixed durations such as 7, 14, or 30 days, and optionally can be refilled for a period of time or number of doses. A patient or their representative provides these prescriptions to one or more pharmacists for dispensing. The pharmacist typically packages the prescribed medication for the required duration and provides these medication(s) to the patient. The asynchronous nature of the prescribing/dispensing process creates timing issues for managing refills. Some patients end up making trips to the pharmacy on a weekly basis (or even more frequently) to refill prescriptions that have run out or have been newly prescribed by one or more medical professionals. Further, pharmacists ideally will verify the prescriptions as being authentic before dispensing certain medications, and interact with insurers and medication managers in order to assure that medications are being properly prescribed, dispensed, and paid for. In some cases, the pharmacist cannot have sufficient stock of a medication; and he or she must order the stock from a central warehouse, from which they are delivered within a few days. This delay forces the patient to return to pick up a prescription instead of having it filled “on-the-spot.”
Also, patients today tend to live more active lifestyles than prior generations; and hence they tend to be away from traditional sources of medications, such as their local pharmacy and doctor's office. At the same time, medication regimens are becoming increasingly precise as to when specific doses must be taken, and medication management providers are increasingly restrictive as to how many doses can be dispensed to a patient. Thus, patients suffer from forgetting to take a timed dosage, losing doses, not having specific doses available when needed, having to manage refills of numerous medications as they run out at inconvenient times, and other issues that inhibit the patient's taking of the necessary doses at the proper time. All of these factors together increase the risk of non-compliance with medication regimens.